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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Lung Cancer

Phase 3

Waitlist Available

Led By Vassiliki Papadimitrakopoulou

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity

Patients must not have had prior treatment with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing nivolumab with or without ipilimumab to see if it can treat patients with squamous cell lung cancer that has come back after previous treatment.

Who is the study for?

This trial is for patients with stage IV squamous cell lung cancer that has returned after treatment. Participants must not have allergies to nivolumab or ipilimumab, no recent steroids or immunosuppressants, no HIV/AIDS, and should be free of certain heart conditions. They can't have had prior treatments targeting immune checkpoints and must not suffer from active autoimmune diseases.

What is being tested?

The study compares the effectiveness of two monoclonal antibodies: nivolumab alone versus nivolumab combined with ipilimumab in treating recurrent lung cancer. It's a phase III trial for those who didn't qualify for other biomarker-driven studies.

What are the potential side effects?

Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in various organs, potential lung issues (pneumonitis), skin reactions, hormone gland problems (like thyroid dysfunction), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have lung disease that causes symptoms or could affect lung toxicity treatment.

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I have not received treatments targeting immune checkpoints.

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I am not allergic to nivolumab or ipilimumab.

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I do not have HIV or AIDS.

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I do not have severe heart disease or recent serious heart issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Investigator-assessed Progression-free Survival (IA-PFS)

Pharmaceutical Preparations

Objective Response Rate

Other study objectives

Screen success rate

Treatment arm randomization acceptance rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (nivolumab, ipilimumab)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (nivolumab)Active Control4 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Ipilimumab

2015